Neffy epinephrine nasal spray 1 mg is now available by prescription in the US for the treatment of Type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 kg to <30 kg.
RT’s Three Key Takeaways:
- Pediatric Access: ARS Pharmaceuticals has launched neffy 1 mg in the US for children weighing 15 to less than 30 kilograms who are at risk for anaphylaxis.
- Improved Safety: The needle-free design eliminates the risk of accidental injections and addresses needle phobia, which can cause caregivers to delay treatment.
- Dosing Reliability: Research indicates that 100% of users successfully administered the nasal spray, compared to error rates of up to 35% with traditional auto-injectors.
ARS Pharmaceuticals announced that neffy (epinephrine nasal spray) 1 mg is now available by prescription in the US for the treatment of Type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 to less than 30 kilograms.
The FDA approved the 1 mg dose in March 2025 for children aged 4 years and older who weigh between 33 and less than 66 pounds, according to a news release. This patient population represents approximately 23% of individuals who require epinephrine for severe allergic reactions.
The needle-free delivery system is designed to address common barriers to emergency treatment, such as needle phobia and the complexity of injection devices.
“Many children fear needles, which can lead parents to delay administering needle-based epinephrine treatments. This delay may result in serious consequences,” said Eric Karas, chief commercial officer of ARS Pharma, in a news release.
Karas added that the design eliminates the risk of accidental injections into the hands or fingers of caregivers, which occurs approximately 3,500 times annually. He noted that the availability of the 1 mg dose arrives ahead of summer travel, camps, and the back-to-school season.
Data from human factor studies demonstrated that 100% of users successfully administered the medication with the nasal spray, while traditional injection devices showed error rates as high as 35%, according to the company. The device features a 24-month shelf life and remains stable in temperatures up to 122°F. If accidentally frozen, the product can be thawed and used without impacting its reliability.
“The expanded availability of neffy represents real progress for our community, especially for young children who may be more likely to speak up about symptoms of a serious allergic reaction when they know epinephrine can be given without a needle,” said Sung Poblete, PhD, RN, chief executive officer of Food Allergy Research & Education (FARE), in a news release.
ARS Pharma reported that it is working with national insurance companies, including United Healthcare, Express Scripts, and OptumRx, to expand commercial coverage. Eligible commercially insured patients may pay as little as $25 for two single-use devices through a co-pay savings program. The company also provides support programs for patients, caregivers, and healthcare professionals to assist with medication fulfillment and insurance requirements.
“We are making great progress with United Healthcare, Express Scripts, OptumRx and others, recognizing the value of neffy and we anticipate expanding commercial coverage over the summer so people can get neffy without restrictions or additional paperwork from physicians,” said Richard Lowenthal, co-founder, president, and chief executive officer of ARS Pharma, in a news release.
For patients who are uninsured or underinsured, the company offers a patient assistance program to provide the medication at no cost to those who meet eligibility criteria. Additionally, eligible schools can receive the 1 mg dose through a dedicated school program.
